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Osteoarthritis and degenerative joint disease drug suspended

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The use of a drug for the treatment osteoarthritis and degenerative joint diseases has been suspended following a review of its medicinal pros and cons.

The European drugs regulator, the European Medicines Agency (EMA), has concluded that the benefits of diacerein do not trump its side effects, particularly the risk of severe diarrhoea and potentially harmful effects on the liver.

Diacerein is a slow-acting medicine that blocks the actions of interleukin‑1 beta, a protein involved in the cartilage destruction and inflammation typical of degenerative joint diseases such as osteoarthritis.

The move follows a review carried out by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), at the behest of the French medicines agency (ANSM) last November.

ANSM raised concerns about the frequency and severity of gastrointestinal side effects such as diarrhoea and liver disorders in association with the drug. The French agency also considered the evidence of diacerein’s benefit in osteoarthritis to be weak.

Although diacerein is known to cause diarrhoea, the PRAC concluded that the number of such cases, particularly of severe diarrhoea, which sometimes led to complications, was high. The Committee was also concerned about liver problems that had been reported in some patients taking the medicine.

The PRAC considered that the available data showed the benefits of diacerein to be limited, and it therefore recommended that medicines containing diacerein be suspended in the EU until convincing evidence showing more pros than cons in a specific group of patients is found.

The PRAC recommendation will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration at its meeting next month.

If the CMDh position is agreed by consensus, the agreement will be implemented directly by the member states where the medicines are authorised. Should the CMDh position be adopted by majority vote, the European Commission will then take an EU-wide legally binding decision.

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